Methods of filling bone using bone cement mixing and delivery devices

ABSTRACT

Methods of filling bone cavities are provided. The methods use a bone cement mixing and delivery device that includes a shaft extending along an axis from a first end to a second end and including a passageway. The first end includes an adapter having a first opening that is in communication with the passageway. The second end includes a second opening that is in communication with the passageway. The shaft includes a mixing portion between the first and second ends. A connector includes a central portion that that is coupled to the adapter. The central portion includes a channel that is in communication with the first opening. The connector includes first and second ports that extend from the central portion. The first port includes a first lumen that is in communication with the channel. The second port includes a second lumen that is in communication with the channel.

FIELD

The present disclosure generally relates to methods of using medicaldevices for bone repair, and more particularly to methods for mixing anddispensing bone cement or other materials.

BACKGROUND

Many medical procedures employ medical grade cement in connection withthe restoration and strengthening of bone structures. During suchprocedures, cement is typically dispensed to a bone to fill in voids orspaces in the bone or between medical devices or implants attached to orembedded within the bone. These dispensing devices may include devicesas simple as syringes and as complex as electronically controlledvalves.

Due to the medical nature of some procedures, the amount and placementof the flowable cement in some situations may need to be administeredunder pressure. For example, some bone cements are highly viscous andrequire significant pressure to expel the bone cement from a dispensingdevice, such as, for example, a syringe. Despite the simplicity orcomplexity of the dispensing device, control over when, where, how muchand at what pressure cement is dispensed is of concern. Currently, thereis a need for a mixing and delivery device for cement that utilizespressure to mix and deliver cement and would permit for fewer steps orless complicated steps in dispensing the flowable cement to the targettissue site, such as a bone cavity (e.g., bone void, bone defect, bonefracture, etc.). This disclosure describes improvements over these priorart technologies.

SUMMARY

The bone cement mixing and delivery device provided allows mixing offlowable components and then delivery of the bone cement withouttransfer to a separate mixing device. The bone cement mixing anddelivery device provided, in some embodiments, comprises a sealeddelivery device that allows a portion of the flowable bone cement to bedispensed by controlled delivery in multiple doses to various targettissue sites without the need to reload new bone cement in the device.In some embodiments, the bone cement mixing and delivery device providedallows an unlimited working time for the physician to apply the bonecement to the target tissue site. In some embodiments, the bone cementmixing and delivery device provided increases physician safety bydecreasing the radiation exposure as the bone cement mixing and deliverydevice, in some embodiments, is a sufficient length (e.g., at least 48inches) to keep the physician out of the fluoroscopic field.

In one exemplary embodiment, there is a method of filling a bone cavitywith a bone cement, the method, comprising: filling the bone cavity withthe bone cement delivered from a bone mixing and delivery device havingan elongated shaft extending along a longitudinal axis from a first endto a second end and comprising an inner surface defining a passageway,the first end comprising an adapter comprising an inner surface defininga first opening that is in communication with the passageway, the secondend comprising a second opening that is in communication with thepassageway, the shaft comprising a mixing portion between the first andsecond ends; and a connector comprising a central portion that that iscoupled to the adapter, the central portion comprising an inner surfacedefining a channel that is in communication with the first opening, theconnector comprising first and second ports that extend from the centralportion, the first port comprising an inner surface defining a firstlumen that is in communication with the channel, the second portcomprising an inner surface defining a second lumen that is incommunication with the channel.

In another exemplary embodiment, there is a method of filling a bonecavity with a bone cement, the method comprising: filling the bonecavity with the bone cement delivered from a bone mixing and deliverydevice having an elongated shaft extending along a longitudinal axisfrom a first end to a second end and comprising an inner surfacedefining a passageway, the first end comprising a first opening that isin communication with the passageway, the second end comprising a secondopening that is in communication with the passageway, the shaftcomprising a mixing portion between the first and second ends; aconnector coupled to the first end and comprising first and secondportions each extending from a central portion of the connector, thefirst portion comprising an inner surface defining a first lumen that isin communication with the first opening, the second portion comprisingan inner surface defining a second lumen that is in communication withthe first opening; a first tube disposed in the first lumen comprisingan inner surface defining a first pathway configured for disposal of afirst component of a bone cement; a second tube disposed in the secondlumen comprising an inner surface defining a second pathway configuredfor disposal of a second component of the bone cement; a first plungermovably disposed in the first pathway and configured to move the firstcomponent from the first pathway and into the passageway; and a secondplunger movably disposed in the second lumen and configured to move thesecond component from the second pathway and into the passageway.

In yet another exemplary embodiment, there is a method of filling a bonecavity with a bone cement, the method comprising: filling the bonecavity with the bone cement delivered from a bone mixing and deliverydevice having an elongated shaft extending along a longitudinal axisfrom a first end to a second end and comprising an inner surfacedefining a passageway, the first end comprising an adapter comprising aninner surface defining a first opening that is in communication with thepassageway, the second end comprising a second opening that is incommunication with the passageway, the shaft comprising a mixing portionbetween the first and second ends, the mixing portion comprising aninner surface having a helical configuration and defining a staticvortex mixer; a connector comprising a central portion that that iscoupled to the adapter, the central portion comprising an inner surfacedefining a channel that is in communication with the first opening, thecentral portion extending parallel to the longitudinal axis andcomprising an aperture that is in communication with the channel, theconnector comprising first and second ports that extend from the centralportion, the first port comprising an inner surface defining a firstlumen that is in communication with the channel, the second portcomprising an inner surface defining a second lumen that is incommunication with the channel, the first and second ports eachextending at an acute angle relative to the longitudinal axis, the firstand second ports extending at inverse angles relative to one another;the bone cement comprising separate first and second components that areeach a flowable composition; a first cartridge coupled to the first portand a second cartridge coupled to the second port, the first cartridgecomprising the first component and the second cartridge comprising thesecond component; a first syringe coupled to the first cartridge andconfigured to move the first component out of the first cartridge andinto the channel; a second syringe coupled to the second cartridge andconfigured to move the second component out of the second cartridge andinto the channel; and a plunger that extends through the aperture andinto the channel to move the first and second components from thechannel and into the passageway.

Accordingly, a bone cement mixing and delivery device is provided thatcomprises an elongated shaft extending along a longitudinal axis from afirst end to a second end. The shaft comprises an inner surface defininga passageway. The first end comprises an adapter comprising an innersurface defining a first opening that is in communication with thepassageway. The second end comprises a second opening that is incommunication with the passageway. The shaft comprises a mixing portionbetween the first and second ends. A connector comprises a centralportion that that is coupled to the adapter. The central portioncomprises an inner surface defining a channel that is in communicationwith the first opening. The connector comprises first and second portsthat extend from the central portion. The first port comprises an innersurface defining a first lumen that is in communication with thechannel. The second port comprises an inner surface defining a secondlumen that is in communication with the channel.

In one embodiment, there is a bone cement mixing and delivery device,comprising: an elongated shaft extending along a longitudinal axis froma first end to a second end and comprising an inner surface defining apassageway, the first end comprising an adapter comprising an innersurface defining a first opening that is in communication with thepassageway, the second end comprising a second opening that is incommunication with the passageway, the shaft comprising a mixing portionbetween the first and second ends; and a connector comprising a centralportion that that is coupled to the adapter, the central portioncomprising an inner surface defining a channel that is in communicationwith the first opening, the connector comprising first and second portsthat extend from the central portion, the first port comprising an innersurface defining a first lumen that is in communication with thechannel, the second port comprising an inner surface defining a secondlumen that is in communication with the channel.

In another embodiment, there is a bone cement mixing and deliverydevice, comprising: an elongated shaft extending along a longitudinalaxis from a first end to a second end and comprising an inner surfacedefining a passageway, the first end comprising a first opening that isin communication with the passageway, the second end comprising a secondopening that is in communication with the passageway, the shaftcomprising a mixing portion between the first and second ends; aconnector coupled to the first end and comprising first and secondportions each extending from a central portion of the connector, thefirst portion comprising an inner surface defining a first lumen that isin communication with the first opening, the second portion comprisingan inner surface defining a second lumen that is in communication withthe first opening; a first tube disposed in the first lumen comprisingan inner surface defining a first pathway configured for disposal of afirst component of a bone cement; a second tube disposed in the secondlumen comprising an inner surface defining a second pathway configuredfor disposal of a second component of the bone cement; a first plungermovably disposed in the first pathway and configured to move the firstcomponent from the first pathway and into the passageway; and a secondplunger movably disposed in the second lumen and configured to move thesecond component from the second pathway and into the passageway.

In yet another embodiment, there is a bone cement mixing and deliverydevice, comprising: an elongated shaft extending along a longitudinalaxis from a first end to a second end and comprising an inner surfacedefining a passageway, the first end comprising an adapter comprising aninner surface defining a first opening that is in communication with thepassageway, the second end comprising a second opening that is incommunication with the passageway, the shaft comprising a mixing portionbetween the first and second ends, the mixing portion comprising aninner surface having a helical configuration and defining a staticvortex mixer; a connector comprising a central portion that that iscoupled to the adapter, the central portion comprising an inner surfacedefining a channel that is in communication with the first opening, thecentral portion extending parallel to the longitudinal axis andcomprising an aperture that is in communication with the channel, theconnector comprising first and second ports that extend from the centralportion, the first port comprising an inner surface defining a firstlumen that is in communication with the channel, the second portcomprising an inner surface defining a second lumen that is incommunication with the channel, the first and second ports eachextending at an acute angle relative to the longitudinal axis, the firstand second ports extending at inverse angles relative to one another;bone cement comprising separate first and second components that areeach a flowable paste; a first cartridge coupled to the first port and asecond cartridge coupled to the second port, the first cartridgecomprising the first component and the second cartridge comprising thesecond component; a first syringe coupled to the first cartridge andconfigured to move the first component out of the first cartridge andinto the channel; a second syringe coupled to the second cartridge andconfigured to move the second component out of the second cartridge andinto the channel; and a plunger that extends through the aperture andinto the channel to move the first and second components from thechannel and into the passageway.

Other features and advantages of the present disclosure will becomeapparent from the following detailed description. It should beunderstood, however, that the detailed description and the specificexamples, while indicating preferred embodiments of the disclosure, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the disclosure will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a side view, in part phantom, of one embodiment of componentsof a bone cement mixing and delivery device in accordance with theprinciples of the present disclosure;

FIG. 2 is a side view of components of the device shown in FIG. 1;

FIG. 3 is a side view of one embodiment of components of a bone cementmixing and delivery device in accordance with the principles of thepresent disclosure;

FIG. 4 is an enlarged side view of components of the device shown inFIG. 3; and

FIG. 5 is side view of components of the device shown in FIG. 3.

Like reference numerals indicate similar parts throughout the figures.

It is to be understood that the figures are not drawn to scale. Further,the relation between objects in a figure may not be to scale, and may infact have a reverse relationship as to size. The figures are intended tobring understanding and clarity to the structure of each object shown,and thus, some features may be exaggerated in order to illustrate aspecific feature of a structure.

DETAILED DESCRIPTION

The exemplary embodiments of a bone cement mixing and delivery deviceand related methods are discussed in terms of medical devices for thetreatment of skeletal injuries, disorders and repairs and moreparticularly, in terms of a bone cement mixing and delivery device andmethod for bone repair. It is envisioned that the device and method maybe employed in applications such as correction of cracks, fissures,voids, e.g., due to osteoporosis or other diseases or injuries. Inaddition, the device and method may be employed with the placement ofsupport structures or devices attached to or embedded within bone. Forexample, such structures may include pins, screws, replacement joints(e.g., of the hip, knee, shoulder), etc.

The bone cement mixing and delivery device provided allows mixing offlowable components and then delivery of the bone cement withouttransfer to a separate mixing device. The bone cement mixing anddelivery device provided, in some embodiments, comprises a sealeddelivery device that allows a portion of the flowable bone cement to bedispensed by controlled delivery in multiple doses to various targettissue sites without the need to reload new bone cement in the device.In some embodiments, the bone cement mixing and delivery device providedallows an unlimited working time for the physician to apply the bonecement to the target tissue site. The bone cement mixing and deliverydevice provided increases physician safety by decreasing the radiationexposure as the bone cement mixing and delivery device, in someembodiments, is a sufficient length (e.g., at least 48 inches) to keepthe physician out of the fluoroscopic field.

In some embodiments, the bone cement mixing and delivery device isconfigured for mixing and delivery of a two-part, partially polymerizedflowable cement paste. In some embodiments, the bone cement mixing anddelivery device includes hydraulic cylinders that are used to providepressure to both mix the cement within a bone cement mixing and deliverydevice and deliver the cement to a surgical site, such, as, for example,a damaged and/or fractured bone. In some embodiments, the cementcomprises a two-part flowable paste that allows for instant delivery andrequires little user involvement.

Due to the viscosity of each of the two flowable bone cement components(e.g., pastes, gels, etc.) force is required to mix the two componentsinto the cement and/or deliver the cement to a surgical site. In someembodiments, the bone cement mixing and delivery device includes apressure syringe, such as, for example, a hydraulic pump (e.g., KyphonCement Delivery System CDS) that engages the components of the flowablebone cement. For example, the hydraulic pump (e.g., Kyphon CementDelivery System CDS) engages 48 and 50 of FIG. 1 or 174 and 176 of FIG.3 either directly or indirectly through a connector to create pressurethat moves the components of the flowable bone cement into the mixingportion 32 to mix the two components into a cement and/or deliver thecement to a surgical site out of opening 30.

In some embodiments, the bone cement mixing and delivery device includesa Y adapter that includes two ports each having a hydraulic pump coupledthereto and a bone filler device (BFD) with a static mixer that iscoupled to the Y adapter such that the cement can be directly injectedinto the target tissue site of the patient easily by utilizing highpressure capability of the hydraulic pumps. In some embodiments, thehydraulic pumps are configured to be independently operated. In someembodiments, the bone cement mixing and delivery device includes one ormore in-line hydraulic valves, such as, for example, check valves,proportioning valves, flow divider valves, etc. In some embodiments, thebone cement mixing and delivery device includes one or more means toadjust mixture ratios of the two pastes, such as, for example, adjustingthe diameter of cartridges that are coupled to the Y adapter and includethe pastes, adjusting pressure delivered to each cartridge, addingin-line flow control valves, etc.

It is contemplated that one or all of the components of the bone cementmixing and delivery device may be disposable, peel-pack, pre-packedsterile devices. One or all of the components of the bone cement mixingand delivery device may be reusable. The bone cement mixing and deliverydevice may be configured as a kit with multiple sized and configuredcomponents.

In some embodiments, the bone cement mixing and delivery device may beconfigured to mix the two components of the bone cement according to adesired ratio based on weight to weight, volume to volume, weight tovolume of each component (e.g. component 1 to component 2, ratio can be1:1 wt. % to wt. %, vol % to vol %, or wt. % to vol %).

It is envisioned that the present disclosure may be employed to treat orrepair bone injuries or disorders such as, for example, osteoporosis,joint replacement, fracture repairs, bone breaks, etc. It iscontemplated that the present disclosure may be employed with otherosteal and bone related applications, including those associated withdiagnostics and therapeutics, such as the delivery of a therapeuticagents to a site for treatment or the delivery of radio opaque markersfor tracking fluid once it is released into a patient. It is furthercontemplated that the disclosed bone cement delivery device and methodsmay be alternatively employed in a surgical treatment with a patient ina prone or supine position, and/or employs various surgical approaches,including anterior, posterior, posterior mid-line, direct lateral,postero-lateral, antero-lateral approaches, etc. in any body region. Thedevice and methods of the present disclosure may also be used onanimals, bone models and other non-living substrates, such as, forexample, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), in an effort toalleviate signs or symptoms of the disease or condition. Alleviation canoccur prior to signs or symptoms of the disease or condition appearing,as well as after their appearance. Thus, treating or treatment includespreventing or prevention of disease or undesirable condition (e.g.,preventing the disease from occurring in a patient, who may bepredisposed to the disease but has not yet been diagnosed as having it).In addition, treating or treatment does not require complete alleviationof signs or symptoms, does not require a cure, and specifically includesprocedures that have only a marginal effect on the patient. Treatmentcan include inhibiting the disease, e.g., arresting its development, orrelieving the disease, e.g., causing regression of the disease. Forexample, treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligament,bone and other tissues; as an adjunct in surgery; and/or any repairprocedure. Also, as used in the specification and including the appendedclaims, the term “tissue” includes soft tissue, ligaments, tendons,cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of the mixing anddelivery device and related methods of employing the device inaccordance with the principles of the present disclosure. Alternateembodiments are also disclosed. Reference will now be made in detail tothe exemplary embodiments of the present disclosure, which areillustrated in the accompanying figures. Turning now to FIGS. 1 and 2,there are illustrated components of a bone cement mixing and deliverydevice 10 including a bone cement mixing and delivery device 12 inaccordance with the principles of the present disclosure.

The components of device 10 can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics and bone material and/or theircomposites, depending on the particular application and/or preference ofa medical practitioner. For example, the components of device 10,individually or collectively, can be fabricated from materials such asstainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (e.g., Nitinol,super elasto-plastic metals, such as GUM METAL® manufactured by ToyotaMaterial Incorporated of Japan), ceramics and composites thereof such ascalcium phosphate (e.g., SKELITE manufactured by Biologix Inc.),thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, and their combinations.

Various components of device 10 may have material composites, includingthe above materials, to achieve various desired characteristics such asstrength, rigidity, elasticity, compliance, biomechanical performance,durability and radiolucency or imaging preference. The components ofdevice 10, individually or collectively, may also be fabricated from aheterogeneous material such as a combination of two or more of theabove-described materials. The components of device 10 may bemonolithically formed, integrally connected or include fasteningelements and/or instruments, as described herein.

Device 10 is employed, for example, with an open, mini-open or minimallyinvasive surgical technique to fill voids, provide patches, attachprosthetic devices, etc., or any other bone related repairs. Device 12includes a bone filler device (BFD), such as, for example, an elongatedshaft 14 extending along a longitudinal axis A from an end 16 to an end18 that is opposite end 16. Shaft 14 comprises a portion 14A adjacentend 16 and a portion 14B adjacent end 18. Shaft 14 has a tapered portion14C between portions 14A, 14B. Shaft 14 comprises an inner surfacedefining a passageway 20. Passageway 20 has a first diameter throughportion 14A and a second diameter though portion 14B that is less thanthe first diameter. Shaft 14 has a length defined by the distancebetween end 16 and end 18. In some embodiments, the length of shaft 14is sufficient to keep a medical practitioner out of the radiation areafrom the fluoroscope. In some embodiments, a cement delivery system suchas a CDS gun available from Kyphon Sarl which contains a 4 inch tethercan engage the device 10 at 48 of FIG. 1 that is a sufficient length(e.g., at least 48 inches) to keep the medical practitioner out of theradiation area generated by the fluoroscope. In some embodiments, thelength of shaft 14 is sufficient to keep a medical practitioner asufficient distance from a radiation source, such as, for example, afluoroscope, when end 18 is positioned adjacent a surgical site, suchas, for example a damaged or fractured bone, such as, for example, oneor more vertebrae.

In some embodiments, shaft 14 comprises a rigid material such that shaft14 cannot be bent without breaking. In some embodiments, shaft 14comprises a flexible material such that shaft 14 can bent withoutbreaking. In some embodiments, shaft 14 comprises a transparent and/ortranslucent material that permits a medical practitioner to viewmaterials disposed within passageway 20 to determine whether componentsof a bone cement are adequately mixed, for example, as will be discussedin greater detail hereinbelow. In some embodiments, end 18 defines ablunt tip of shaft 14 that is configured to prevent penetration oftissue and/or other injury to tissue. In some embodiments, end 18 isrounded to prevent penetration of tissue and/or other injury to tissue.In some embodiments, passageway 20 may be disposed at alternateorientations, relative to axis A, such as, for example, parallel,transverse, perpendicular and/or other angular orientations such asacute or obtuse, co-axial and/or may be offset or staggered. In someembodiments, an outer surface of shaft 14 comprises a series ofgraduated markings 25 configured to indicate the depth shaft 14 has beeninserted into a surgical site or pathway, for example.

End 16 comprises an adapter 22 comprising a pair of arms 24 that extendparallel to one another and are configured for gripping by a medicalpractitioner to selectively position and/or move device 12. In someembodiments, adapter 22 is fixed to shaft 14. Adapter 22 comprises aninner surface defining an opening 26 that is in communication withpassageway 20. In some embodiments, opening 26 includes an internalthread form configured to engage an external thread form of a connector28 to couple connector 28 to adapter 22, as will be discussed in greaterdetail hereinbelow. End 18 comprises an opening 30 that is incommunication with passageway 20. Shaft 14 comprises a mixing portion 32between ends 16 and 18. The inner surface of shaft 14 that definespassageway 20 has a helical configuration through portion 32 to define astatic vortex mixer configured to mix two separate flowable componentsof the bone cement BC, as will be discussed in greater detailhereinbelow. This static vortex mixer can be embedded in the elongatedshaft to enhance mixing of the two components of the bone cement.

The inner surface of shaft 14 that defines passageway 20 is integrallyformed and/or monolithic with shaft 14 such that the static vortex mixerdefined by the helical portion of passageway 20 is permanently fixedrelative to shaft 14. In some embodiments, portion 138 may be variouslyconfigured and can have a configuration that adequately mixes the firstand second components of bone cement BC as the first and secondcomponents of bone cement BC passes through portion 138.

Due to the configuration of shaft 14 discussed above, opening 26 has awidth or diameter that is greater than that of opening 30. In someembodiments, opening 26 and/or opening 30 may have various cross sectionconfigurations, such as, for example, oval, oblong, triangular,rectangular, square, polygonal, irregular, uniform, non-uniform,variable, tubular and/or tapered. In some embodiments, opening 26 and/oropening 30 may be disposed at alternate orientations, relative to axisA, such as, for example, parallel, transverse, perpendicular and/orother angular orientations such as acute or obtuse, co-axial and/or maybe offset or staggered. In some embodiments, adapter 22 comprises amaterial that is different than the material that forms shaft 14. Insome embodiments, adapter 22 comprises molded plastic and shaft 14comprises metal. In some embodiments, connector 28 can be variouslyconnected with adapter 22, such as, for example, monolithic, integralconnection, frictional engagement, threaded engagement, mutual grooves,screws, adhesive, nails, barbs and/or raised element.

Connector 28 comprises a central portion 34 that that is coupled toadapter 22. As discussed above, portion 34 comprises an external threadform that engages an internal thread form of opening 26 to coupleconnector 28 with adapter 22. Portion 34 comprises an inner surfacedefining a channel 36 that is in communication with opening 26.Connector 28 comprises ports 38, 40 that extend from portion 34. Port 38comprises an inner surface defining a lumen 42 that is in communicationwith channel 36. Port 40 comprises an inner surface defining a lumen 44that is in communication with channel 36. Port 38 and port 40 eachextend at an acute angle relative to axis A. In some embodiments, ports38 and 40 extend at inverse angles relative to one another. Portion 34extends parallel to axis A and comprises an aperture 46 that is incommunication with channel 36. It will be understood by those ofordinary skill in the art that portion 34 is optional and, in someembodiments, portion 34 is not necessary.

In some embodiments, channel 36, lumen 42, lumen 44 and/or aperture 46may have various cross section configurations, such as, for example,circular, oval, oblong, triangular, rectangular, square, polygonal,irregular, uniform, non-uniform, variable, tubular and/or tapered. Insome embodiments, connector 28 comprises a cap 46 that covers aperture46 when aperture 46 is not in use, as will be discussed in greaterdetail hereinbelow. In some embodiments, connector 28 can be variouslyconnected with adapter 22, and/or cap 46 can be variously connected withconnector 28, such as, for example, monolithic, integral connection,frictional engagement, threaded engagement, mutual grooves, screws,adhesive, nails, barbs and/or raised element.

In some embodiments, a cartridge 48 is coupled to port 38 and acartridge 50 substantially similar to cartridge 48 is coupled to port40. In some embodiments, port 38 comprises an external thread form thatengages an internal thread form of cartridge 48 to couple cartridge 48to port 38 and port 40 comprises an external thread form that engages aninternal thread form of cartridge 50 to couple cartridge 50 to port 40.Cartridge 48 includes a cavity having a first flowable paste componentof cement BC disposed therein and cartridge 50 includes a cavity havinga second flowable paste component of cement BC disposed therein. In someembodiments, cartridge 48 can be variously connected with port 38 and/orcartridge 50 can be variously connected with port 40, such as, forexample, monolithic, integral connection, frictional engagement,threaded engagement, mutual grooves, screws, adhesive, nails, barbsand/or raised element.

In some embodiments, bone cement BC comprises a poly(methylmethacrylate) (PMMA); methyl methacrylate (MMA); calcium phosphate; aresorbable polymer, such as, for example, PLA, PGA or combinationsthereof; a resorbable polymer with allograft, such as, for example,particles or fibers of mineralized bone; Plexur® sold by Osteotech,Inc., and combinations thereof. In some embodiments, bone cement BC is ahigh viscosity bone cement. In some embodiments, bone cement BC has aviscosity that is at least 500 Pascal-sec (Pa-s) to infiltrate a medicalsite and prevent any migration of bone cement BC during medicalprocedures. In some embodiments, bone cement BC has a viscosity that isat least 600 Pa-s. In some embodiments, bone cement BC has a viscositythat is at least 800 Pa-s. In some embodiments, bone cement BC has aviscosity that is at least 1,000 Pa-s. In some embodiments, bone cementBC comprises a polymerization accelerator.

In some embodiments, a syringe is coupled to cartridge 48 and isconfigured to move the first component of bone cement BC out of thecartridge 48 and into channel 36 and another syringe is coupled tocartridge 50 and is configured to move the second component of bonecement BC out of cartridge 50 and into channel 36. In some embodiments,the syringes are hydraulic pumps available from Kyphon Sarl as part ofKyphon's Cement Delivery System (CDS). In some embodiments, the syringesare coupled directly to cartridges 48, 50. In some embodiments, thesyringes are coupled to cartridges 48, 50 via tubing having a material,such as, for example, a hydraulic fluid disposed therein such that oneof the syringes moves the hydraulic fluid through one of the tubing suchthat the hydraulic fluid applies a force upon a piston movablypositioned in cartridge 48 such that the piston moves the firstcomponent of bone cement BC out of cartridge 48 and into lumen 42 andanother one of the syringes moves the hydraulic fluid through the othertubing such that the hydraulic fluid applies a force upon a pistonmovably positioned in cartridge 50 such that the piston moves the secondcomponent of bone cement BC out of cartridge 50 and into lumen 44. Thefirst component of bone cement BC moves from lumen 42 into channel 36and the second component of bone cement BC moves from lumen 44 intochannel 36.

In some embodiments, device 10 includes a plunger movably positioned inchannel 36. In some embodiments, the plunger is slidably disposed inchannel 36 such that a distal end of the plunger engages the first andsecond components of bone cement BC that are disposed in channel 36.Moving the plunger along axis A in the direction shown by arrow B thusmoves the first and second components of bone cement BC from channel 36,through opening 26 and into portion 14A. Moving the plunger along axis Afurther in the direction shown by arrow B moves the first and secondcomponents of bone cement BC from portion 14A into portion 32 where thefirst and second components of bone cement BC are mixed with one anotherin the static mixer defined by portion 32. Bone cement BC is moved fromportion 32 and into portion 14B, where bone cement BC is fully mixed.Pressure created by the syringes and/or the plunger moves fully mixedbone cement BC from portion 14B out of shaft 14 via opening 30 todeliver fully mixed bone cement BC to a surgical site, such as, forexample, a damaged or fractured bone. In some embodiments, the hydraulicfluid is saline. The hydraulic fluid does not contact the components ofthe bone cement.

In assembly, operation and use, device 10 is employed with a surgicalprocedure, such as, for a treatment of bone injuries, to provide bonerepairs, to strengthen or rebuild bones, etc. It is contemplated thatone or all of the components of device 10 can be delivered as apre-assembled device or can be assembled in situ. Device 10 may becompletely or partially revised, removed or replaced.

Device 10 and accessories thereof, described above, can be employedduring a surgical procedure for dispensing bone cement BC. In use, amedical practitioner obtains access to a surgical site including a bone,such as, for example, a vertebra in need of repair, in any appropriatemanner, such as, for example, through incision and retraction oftissues. It is envisioned that device 10 can be used in any existingsurgical method or technique including open surgery, mini-open surgery,minimally invasive surgery and percutaneous surgical implantation,whereby the bone is accessed through a mini-incision, or sleeve thatprovides a protected passageway to the area. In some embodiments, thevoid in the bone to be filled is created using an inflatable bone tampby inserting a balloon of the inflatable bone tamp into bone, such as,for example, cancellous bone and expanding the balloon to create thevoid. In some embodiments, the void in the bone to be filled is creatednaturally and/or by injury to the patient. In some embodiments, the voidin the bone is created during part of a surgical procedure.

An incision is made in the body of a patient and a cutting instrumentcreates a surgical pathway for insertion of components of device 10,such as, for example, shaft 14. A preparation instrument can be employedto prepare tissue surfaces of the bone, as well as for aspiration andirrigation of a surgical region according to the requirements of aparticular surgical application. In some embodiments, shaft 14 isinserted into the surgical pathway such that opening 30 is positionedadjacent hole(s), fracture(s), void(s), depression(s), etc. in the bonethat the medical practitioner desires to fill, at least partly, withbone cement BC to maintain or improve the bone's structural integrity.Significantly, the length of shaft is sufficient to position a medicalpractitioner out of the radiation area from the fluoroscope. In someembodiments, a cement delivery system such as a CDS gun available fromKyphon Sarl which contains a 4 inch tether can engage the device 10 at48 of FIG. 1 that is a sufficient length (e.g., at least 48 inches) tokeep the medical practitioner out of the radiation area generated by thefluoroscope. That is, the length of shaft 14 is sufficient to keep amedical practitioner a sufficient distance from a radiation source, suchas, for example, a fluoroscope, when end 18 is positioned adjacent asurgical site, such as, for example a damaged or fractured bone, suchas, for example, one or more vertebrae.

The syringe coupled to cartridge 48 is actuated to move the hydraulicfluid in the syringe coupled to cartridge 48 through one of the tubingsuch that the hydraulic fluid applies a force upon the piston movablypositioned in cartridge 48 such that the piston moves the firstcomponent of bone cement BC out of cartridge 48 and into lumen 42. Thesyringe coupled to cartridge 50 is actuated to move the hydraulic fluidthrough the other tubing such that the hydraulic fluid applies a forceupon the piston movably positioned in cartridge 50 such that the pistonmoves the second component of bone cement BC out of cartridge 50 andinto lumen 44. The first component of bone cement BC moves from lumen 42into channel 36 and the second component of bone cement BC moves fromlumen 44 into channel 36.

Cap 45 is removed from portion 34 such that the plunger is insertedthrough aperture 46 and into channel 36. The plunger is translatedwithin channel 36 along axis A in the direction shown by arrow B to movethe first and second components of bone cement BC from channel 36,through opening 26 and into portion 14A. The plunger is further movedalong axis A in the direction shown by arrow B to move the first andsecond components of bone cement BC from portion 14A into portion 14C.In some embodiments, the plunger is stopped from translating withinpassageway 20 along axis A before the plunger enters portion 32. That isthe plunger does not enter portion 32. As the pressure created by thesyringes and/or the plunger moves fully mixed bone cement BC movethrough portion 32, the first and second components of bone cement BCare mixed with one another in the static mixer defined by portion 32.Pressure created by the syringes and/or the plunger moves fully mixedbone cement BC from portion 32 and into portion 14B. Pressure created bythe syringes and/or the plunger moves fully mixed bone cement BC fromportion 14B out of shaft 14 via opening 30 to deliver fully mixed bonecement BC to a surgical site, such as, for example, a damaged orfractured bone. In some embodiments, bone cement BC is delivered intothe fracture or void in the bone to at least partially fill the fractureor void. In some embodiments, bone cement BC is allowed to cure withinthe facture or void.

In some embodiments, the first and second components of bone cement BCare configured to be mixed with one another such that the firstcomponent of bone cement BC is mixed with the second component of bonecement BC in a selected ratio. In some embodiments, the selected ratiois 1:1. In some embodiments the 1:1 ratio includes a first amount of thefirst component of bone cement BC being mixed with the same amount orsubstantially the same amount of the second component of bone cement BC.In some embodiments the relative amounts of the first and secondcomponents of bone cement BC are in mass, volume, weight or acombination of the same. In some embodiments, to mix the first andsecond components of bone cement BC in a 1:1 ratio, the widths and/ordiameters of cartridges 48, 50 are the same. In some embodiments, to mixthe first and second components of bone cement BC in a 1:1 ratio, theamount of pressure provided to each of cartridges 48, 50 is the same. Insome embodiments, to mix the first and second components of bone cementBC in a 1:1 ratio, an in-line flow control valve is provided to equalizethe amount of pressure in each of cartridges 48, 50 and/or each oflumens 42, 44. In some embodiments, the syringes are moved relative tocartridges 48, 50 simultaneously and at approximately the same rate suchthat the same amount or substantially the same amount of the firstcomponent of bone cement BC moves from cartridge 48, through lumen 42and into passageway 20 as the amount of the second component of bonecement BC that moves from cartridge 50, through lumen 44 and intopassageway 20.

It will be understood that the other ratios of components can be usedand the device can be calibrated to deliver the flowable components atother ratios (e.g., 0.5, 0.25, 0.1 to 1) based on weight, volume andflowability of the components.

In one embodiment, device 10 may also deliver an agent, which may bemixed in the bone cement BC or delivered separately. It is envisionedthat the agent may include bone growth promoting material. In someembodiments, cartridge 48 and/or cartridge 50 are pre-loaded with theagent before the first and second components of bone cement BC areloaded into cartridge 48 and/or cartridge 50. Device 12 then is used toexpel the agent through opening 30 in the same manner as bone cement BCis expelled from opening 30, discussed above, such that the agentpenetrates at least a portion of the bone fracture or void. Device 12 isthen removed from the surgical site through the surgical pathway and thefirst and second components of bone cement BC are loaded into cartridge48 and/or cartridge 50. Fully mixed bone cement BC is then expelled fromopening 30 in the manner discussed above. In some embodiments, device 12is removed from the surgical pathway after the bone is at leastpartially filled with bone cement. Device 12 is then reinserted into thesurgical pathway such that opening 30 is positioned adjacent the atleast partially filled bone. Device 12 then is used to expel the agentthrough opening 30 in the same manner as bone cement BC is expelled fromopening 30 in the manner discussed above.

It is contemplated that the agent may include therapeuticpolynucleotides or polypeptides. It is further contemplated that theagent may include biocompatible materials, such as, for example,biocompatible metals and/or rigid polymers, such as, titanium elements,metal powders of titanium or titanium compositions, sterile bonematerials, such as allograft or xenograft materials, synthetic bonematerials such as coral and calcium compositions, such as HA, calciumphosphate and calcium sulfite, biologically active agents, for example,gradual release compositions such as by blending in a bioresorbablepolymer that releases the biologically active agent or agents in anappropriate time dependent fashion as the polymer degrades within thepatient. Suitable biologically active agents include, for example, BMP,Growth and Differentiation Factors proteins (GDF) and cytokines. Thecomponents of correction device 10 can be made of radiolucent materialssuch as polymers. Radiomarkers may be included for identification underx-ray, fluoroscopy, CT or other imaging techniques. It is envisionedthat the agent may include one or a plurality of therapeutic agentsand/or pharmacological agents for release, including sustained release,to treat, for example, pain, inflammation and degeneration.

It is envisioned that the use of microsurgical and image guidedtechnologies may be employed to access, view and repair bonedeterioration or damage, with the aid of the device 10. Upon completionof the procedure, the surgical instruments and assemblies are removedand the incision is closed.

Turning now to FIGS. 3-5, device 10 includes a bone cement mixing anddelivery device 120 in accordance with the principles of the presentdisclosure. Device 120 comprises a bone filler device (BFD), such as,for example, an elongated shaft 122 extending along a longitudinal axisA1 from an end 124 to an end 126 opposite end 124.

Shaft 122 comprises a portion 122A adjacent end 124 and a portion 122Badjacent end 126. Portion 122A has a width or diameter that is greaterthan that of portion 122B. Shaft 122 has a tapered portion 122C betweenportions 122A, 122B. Shaft 122 comprises an inner surface defining apassageway 138. Passageway 138 has a first diameter through portion 122Aand a second diameter though portion 122B that is less than the firstdiameter. Shaft 122 has a length defined by the distance between end 124and end 126. In some embodiments, the length of shaft 122 is sufficientto keep a medical practitioner out of the radiation area from thefluoroscope. That is, the length of shaft 122 is sufficient to keep amedical practitioner a sufficient distance from a radiation source, suchas, for example, a fluoroscope, when end 126 is positioned adjacent asurgical site, such as, for example a damaged or fractured bone, suchas, for example, one or more vertebrae. End 124 comprises an opening 130that is in communication with passageway 138. End 126 comprises anopening 132 that is in communication with passageway 138.

In some embodiments, shaft 122 comprises a rigid material such thatshaft 122 cannot be bent without breaking. In some embodiments, shaft122 comprises a flexible material such that shaft 122 can bent withoutbreaking. In some embodiments, shaft 122 comprises a transparent and/ortranslucent material that permits a medical practitioner to viewmaterials disposed within passageway 138 to determine whether componentsof a bone cement are adequately mixed, for example, as will be discussedin greater detail hereinbelow. Shaft 122 comprises a mixing portion 138between ends 124, 126. The inner surface of shaft 122 that definespassageway 138 has a helical configuration through portion 138 to definea static vortex mixer configured to mix the first and second componentsof bone cement BC, discussed above. The inner surface of shaft 122 thatdefines passageway 138 is integrally formed and/or monolithic with shaft122 such that the static vortex mixer defined by the helical portion ofpassageway 138 is permanently fixed relative to shaft 122. In someembodiments, portion 138 may be variously configured and can have anconfiguration that adequately mixes the first and second components ofbone cement BC as the first and second components of bone cement BCpasses through portion 138.

In some embodiments, end 126 defines a blunt tip of shaft 122 that isconfigured to prevent penetration of tissue and/or other injury totissue. In some embodiments, end 126 is rounded to prevent penetrationof tissue and/or other injury to tissue. In some embodiments, passageway138 may be disposed at alternate orientations, relative to axis A1, suchas, for example, parallel, transverse, perpendicular and/or otherangular orientations such as acute or obtuse, co-axial and/or may beoffset or staggered. In some embodiments, an outer surface of shaft 122comprises a series of graduated markings 134 configured to indicate thedepth shaft 122 has been inserted into a surgical site or pathway, forexample.

A connector 136 is fixed to shaft 122. Connector 136 comprises a centralportion 140 including an inner surface defining a conduit 142 that is incommunication with opening 130. Connector 136 includes a portion 144extending from portion 140 and a portion 146 extending from portion 140.Portions 144, 146 each extend parallel to axis A1. Portion 144 is spacedapart from portion 146 by a wall 148. Portion 144 comprises an innersurface defining a lumen 150 that is in communication with conduit 142and opening 130. Portion 146 comprises an inner surface defining a lumen152 that is in communication with conduit 142 and opening 130. In someembodiments, connector 136 comprises a transparent and/or translucentmaterial configured to allow a medical practitioner to properly insertshaft 122 into portion 140, a tube 154 into lumen 150 and a tube 156into lumen 152. In some embodiments, they may all be affixed togetherfor example, by glue, adhesive or be formed as one piece. In someembodiments, lumen 150 may be disposed at alternate orientations,relative to axis A1 and/or lumen 152, such as, for example, transverse,perpendicular and/or other angular orientations such as acute or obtuse,co-axial and/or may be offset or staggered. In some embodiments,connector 136 comprises an elastomeric material such that lumen 150and/or lumen 152 can be stretched to increase a width or diameterthereof for insertion of one of tubes 154, 156 and then the width ordiameter of lumen 150 and/or lumen 152 decreases such that innersurfaces of connector 136 that define lumens 150, 152 engage outersurfaces of tubes 154, 156 to fix tubes 154, 156 relative to connector136. In some embodiments, tubes 154, 156 can be variously connected withconnector 136, such as, for example, monolithic, integral connection,frictional engagement, threaded engagement, mutual grooves, screws,adhesive, nails, barbs and/or raised element.

Tube 154 comprises an end 158 positioned in lumen 150 and an end 160opposite end 158. Tube 154 comprises an inner surface defining a pathway162 configured for disposal of the first component of bone cement BC.Tube 156 comprises an end 164 positioned in lumen 152 and an end 166opposite end 164. Tube 156 comprises an inner surface defining a pathway168 configured for disposal of the second component of bone cement BC.In some embodiments, pathway 162 and/or pathway 168 each have a uniformdiameter and a cylindrical cross sectional configuration. End 160comprises an adapter 170 and end 166 comprises an adapter 172.

A plunger 174 is movably disposed in pathway 162 and configured to movethe first component of bone cement BC from pathway 162, through opening130 and into passageway 138. A plunger 174 is movably disposed inpathway 162 and configured to move the first component of bone cement BCfrom pathway 162, through opening 130 and into passageway 138. Aproximal end of plunger 174 comprises a handle 178 and a proximal end ofplunger 176 comprises a handle 180.

An incision is made in the body of a patient and a cutting instrumentcreates a surgical pathway for insertion of components of device 10,such as, for example, shaft 122. A preparation instrument can beemployed to prepare tissue surfaces of the bone, as well as foraspiration and irrigation of a surgical region according to therequirements of a particular surgical application. In some embodiments,shaft 122 is inserted into the surgical pathway such that opening 132 ispositioned adjacent hole(s), fracture(s), void(s), depression(s), etc.in the bone that the medical practitioner desires to fill, at leastpartly, with bone cement BC to maintain or improve the bone's structuralintegrity. Significantly, the length of shaft is sufficient to positiona medical practitioner out of the radiation area from the fluoroscope.That is, the length of shaft 122 is sufficient to keep a medicalpractitioner a sufficient distance from a radiation source, such as, forexample, a fluoroscope, when end 126 is positioned adjacent a surgicalsite, such as, for example a damaged or fractured bone, such as, forexample, one or more vertebrae.

Portion 140 is fitted over end 124 to couple shaft 122 with connector136. End 158 is positioned within lumen 150 and end 164 is positionedwithin lumen 152. The first component of bone cement BC is loaded intopathway 162 and the second component of bone cement BC is loaded intopathway 168. Due to the viscosity of the flowable components that makeup the first and second components of bone cement BC, the firstcomponent of bone cement BC does not move from pathway 162, throughopening 130 and into passageway 138 without the application ofadditional pressure and/or force. Likewise, the second component of bonecement BC does not move from pathway 168, through opening 130 and intopassageway 138 without the application of additional pressure and/orforce.

In order to move the first component of bone cement BC from pathway 162,through opening 130 and into passageway 138 and the second component ofbone cement BC from pathway 168, through opening 130 and into passageway138, plunger 174 is inserted into pathway 162 and plunger 176 isinserted into pathway 168. Plunger 174 is moved relative to shaft 122and/or tube 154 in the direction shown by arrow B such that the firstcomponent of bone cement BC moves from pathway 162, through opening 130and into passageway 138. Plunger 176 is moved relative to shaft 122and/or tube 156 in the direction shown by arrow B such that the secondcomponent of bone cement BC moves from pathway 168, through opening 130and into passageway 138. In some embodiments, plungers 174, 176 aremoved relative to tubes 154, 156 and/or shaft 122 simultaneously and atapproximately the same rate such that the same amount or substantiallythe same amount of the first component of bone cement BC moves frompathway 162, through opening 130 and into passageway 138 as the amountof the second component of bone cement BC that moves from pathway 168,through opening 130 and into passageway 138.

In some embodiments, plunger 174 is moved relative to shaft 122 and/ortube 154 in the direction shown by arrow B until an internal thread formin handle 178 engages an external thread form of adapter 170 and plunger176 is moved relative to shaft 122 and/or tube 156 in the directionshown by arrow B until an internal thread form in handle 180 engages anexternal thread form of adapter 172. This fixes plunger 174 relative totube 154 and/or shaft 122 and fixes plunger 176 relative to tube 156and/or shaft 122. Moving plungers 174, 176 in the direction shown byarrow B until handles 178, 180 engage adapters 170, 172 causes the firstand components of bone cement BC to move through portion 138 such thatthe first and second components of bone cement BC become mixed. Thepressure and/or force created by moving plungers 174, 176 in thedirection shown by arrow B causes fully mixed bone cement BC to moveinto portion 122B and out of opening 132 for delivery to the surgicalsite, such as, for example, a damaged or fractured bone. In someembodiments, bone cement BC is delivered into the fracture or void inthe bone to at least partially fill the fracture or void. In someembodiments, bone cement BC is allowed to cure within the facture orvoid.

In some embodiments, the first and second components of bone cement BCare configured to be mixed with one another such that the firstcomponent of bone cement BC is mixed with the second component of bonecement BC in a selected ratio. In some embodiments, the selected ratiois 1:1. In some embodiments, to mix the first and second components ofbone cement BC in a 1:1 ratio, the widths and/or diameters of pathways162, 168 are the same. In some embodiments, to mix the first and secondcomponents of bone cement BC in a 1:1 ratio, the amount of pressureprovided/created from/by moving plungers 174, 176 in the direction shownby arrow B is the same. In some embodiments, to mix the first and secondcomponents of bone cement BC in a 1:1 ratio, an in-line flow controlvalve is provided to equalize the amount of pressure in each of pathways162, 168. In some embodiments the 1:1 ratio includes a first amount ofthe first component of bone cement BC being mixed with the same amountor substantially the same amount of the second component of bone cementBC. In some embodiments the relative amounts of the first and secondcomponents of bone cement BC are in mass, volume, weight or acombination of the same.

In one embodiment, device 10 may also deliver an agent, which may bemixed in the bone cement BC or delivered separately. It is envisionedthat the agent may include bone growth promoting material. In someembodiments, pathway 162 and/or pathway 168 are pre-loaded with theagent before the first and second components of bone cement BC areloaded into pathway 162 and/or pathway 168. Device 120 then is used toexpel the agent through opening 132 in the same manner as bone cement BCis expelled from opening 132, discussed above, such that the agentpenetrates at least a portion of the bone fracture or void. Device 120is then removed from the surgical site through the surgical pathway andthe first and second components of bone cement BC are loaded intopathway 162 and/or pathway 168. Fully mixed bone cement BC is thenexpelled from opening 132 in the manner discussed above. In someembodiments, device 120 is removed from the surgical pathway after thebone is at least partially filled with bone cement. Device 120 is thenreinserted into the surgical pathway such that opening 132 is positionedadjacent the at least partially filled bone. Device 120 then is used toexpel the agent through opening 132 in the same manner as bone cement BCis expelled from opening 132.

It is contemplated that the agent may include therapeuticpolynucleotides or polypeptides. It is further contemplated that theagent may include biocompatible materials, such as, for example,biocompatible metals and/or rigid polymers, such as, titanium elements,metal powders of titanium or titanium compositions, sterile bonematerials, such as allograft or xenograft materials, synthetic bonematerials such as coral and calcium compositions, such as HA, calciumphosphate and calcium sulfite, biologically active agents, for example,gradual release compositions such as by blending in a bioresorbablepolymer that releases the biologically active agent or agents in anappropriate time dependent fashion as the polymer degrades within thepatient. Suitable biologically active agents include, for example, BMP,Growth and Differentiation Factors proteins (GDF) and cytokines. Thecomponents of correction device 10 can be made of radiolucent materialssuch as polymers. Radiomarkers may be included for identification underx-ray, fluoroscopy, CT or other imaging techniques. It is envisionedthat the agent may include one or a plurality of therapeutic agentsand/or pharmacological agents for release, including sustained release,to treat, for example, pain, inflammation and degeneration.

It is envisioned that the use of microsurgical and image guidedtechnologies may be employed to access, view and repair bonedeterioration or damage, with the aid of the device 10. Upon completionof the procedure, the surgical instruments and assemblies are removedand the incision is closed.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1.-20. (canceled)
 21. A method of filling a bone cavity with a bonecement, the method comprising: filling the bone cavity with the bonecement delivered from a bone mixing and delivery device having anelongated shaft extending along a longitudinal axis from a first end toa second end and comprising an inner surface defining a passageway, thefirst end comprising an adapter comprising an inner surface defining afirst opening that is in communication with the passageway, the secondend comprising a second opening that is in communication with thepassageway, the shaft comprising a mixing portion between the first andsecond ends; and a connector comprising a central portion that iscoupled to the adapter, the central portion comprising an inner surfacedefining a channel that is in communication with the first opening, theconnector comprising first and second ports that extend from the centralportion, the first port comprising an inner surface defining a firstlumen that is in communication with the channel, the second portcomprising an inner surface defining a second lumen that is incommunication with the channel, wherein the bone mixing and deliverydevice further comprises a first cartridge coupled to the first port anda second cartridge coupled to the second port, a first syringe coupledto the first cartridge; and a second syringe coupled to the secondcartridge.
 22. A method as recited in claim 21, wherein the firstcartridge comprises a first component of the bone cement and the secondcartridge comprises a second component of the bone cement.
 23. A methodas recited in claim 22, wherein the first syringe is configured to movethe first component out of the first cartridge and into the channel; andthe second syringe is configured to move the second component out of thesecond cartridge and into the channel.
 24. A method as recited in claim23, wherein the central portion extends parallel to the longitudinalaxis and comprises an aperture that is in communication with thechannel; and the device comprises a plunger that extends through theaperture and into the channel to move the first and second componentsfrom the channel and into the passageway.
 25. A method as recited inclaim 22, wherein the first and second components of the bone cement arepastes.
 26. A method as recited in claim 22, wherein the first portcomprises an external thread form that engages an internal thread formof the first cartridge to couple the first cartridge to the first portand the second port comprises an external thread form that engages aninternal thread form of the second cartridge to couple the secondcartridge to the second port.
 27. A method as recited in claim 21,wherein the mixing portion comprises a static vortex mixer.
 28. A methodas recited in claim 21, wherein the mixing portion comprises an innersurface having a helical configuration and defining a static vortexmixer.
 29. A method as recited in claim 21, wherein the first and secondports each extend at an acute angle relative to the longitudinal axis.30. A method as recited in claim 29, wherein the first and second portsextend at inverse angles relative to one another.
 31. A method asrecited in claim 21, wherein the adapter comprises a first thread formthat engages a second thread form of the central portion to couple theconnector to the adapter.
 32. A method as recited in claim 21, whereinthe second opening is coaxial with the longitudinal axis.
 33. A methodas recited in claim 21, wherein an outer surface of the shaft comprisesa series of graduated markings configured to indicate insertion depth.34. A method as recited in claim 21, wherein the shaft has a lengthdefined by a distance between the first and second ends, the length ofthe shaft being sufficient to keep a physician a sufficient distancefrom a radiation source when the second end is positioned adjacent asurgical site.
 35. A method as recited in claim 21, wherein the secondend comprises a blunt tip.
 36. A method of filling a bone cavity with abone cement, the method comprising: filling the bone cavity with thebone cement delivered from a bone mixing and delivery device having anelongated shaft extending along a longitudinal axis from a first end toa second end and comprising an inner surface defining a passageway, aconnector coupled to the first end and comprising first and secondlumens each extending from a central portion of the connector, a firsttube disposed in the first lumen comprising an inner surface defining afirst pathway configured for disposal of a first component of a bonecement; a second tube disposed in the second lumen comprising an innersurface defining a second pathway configured for disposal of a secondcomponent of the bone cement; a first plunger movably disposed in thefirst pathway and configured to move the first component from the firstpathway and into the passageway; and a second plunger movably disposedin the second lumen and configured to move the second component from thesecond pathway and into the passageway.
 37. A method as recited in claim36, wherein the first and second tubes extend parallel to one another.38. A method as recited in claim 36, wherein the mixing portioncomprises an inner surface having a helical configuration and defining astatic vortex mixer.
 39. A method as recited in claim 38, wherein thefirst and second components of the bone cement are flowable pastes. 40.A method of filling a bone cavity with a bone cement, the methodcomprising: filling the bone cavity with the bone cement delivered froma bone mixing and delivery device having an elongated shaft extendingalong a longitudinal axis from a first end to a second end andcomprising an inner surface defining a passageway, a connectorcomprising a central portion that is coupled to the adapter, the centralportion comprising an inner surface defining a channel that is incommunication with the first end, the central portion extending parallelto the longitudinal axis and comprising an aperture that is incommunication with the channel, the connector comprising first andsecond ports that extend from the central portion, the first portcomprising an inner surface defining a first lumen that is incommunication with the channel, the second port comprising an innersurface defining a second lumen that is in communication with thechannel, the first and second ports each extending at an acute anglerelative to the longitudinal axis, the first and second ports extendingat inverse angles relative to one another; the bone cement comprisingseparate first and second components that are each a flowablecomposition; a first cartridge coupled to the first port and a secondcartridge coupled to the second port, the first cartridge comprising thefirst component and the second cartridge comprising the secondcomponent; a first syringe coupled to the first cartridge and configuredto move the first component out of the first cartridge and into thechannel; a second syringe coupled to the second cartridge and configuredto move the second component out of the second cartridge and into thechannel; and a plunger that extends through the aperture and into thechannel to move the first and second components from the channel andinto the passageway